An interventional study of Tablets Ibumetin and placebo and Tablets Ibumetin and placebo in Colles Fracture, sponsored by Northern Orthopaedic Division, Denmark. Completed at 1 site in Denmark. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-22.
Sponsored by Northern Orthopaedic Division, Denmark · Not applicable, Interventional, and Treatment
It is believed that some painkillers (NSAID drugs) slow bone healing but the knowledge is based only on experimental studies with animals whose results are automatically translated for humans. The purpose is to examine whether these drugs slow bone healing and what relationship there is between different bone examinations, scan for osteoporosis, bone marker laboratory tests, radiological controls and histology of newly formed bone under a microscope.
One of the most popular painkillers in the world is known as NSAID (non-steroidal anti-inflammatory drugs). Many studies with animals have been made which show a clear tendency for delayed bone healing by taking NSAIDs.
It is known that an early intake of NSAIDs prevents ectopic ossification in patients, receiving total hip prosthesis. However, cases of prosthetic loosening and instability after 10 years were almost exclusively observed in the group of patients who received NSAIDs postoperatively. However, very few clinical studies still show this tendency. In this study we include patients with fresh fracture in the wrist; Colles fracture. The fracture may seem unstable when there is a lack of bone healing. These fractures are very common in the orthopaedic clinic.
Although there is no dislocation of the fragments, newly formed bone can be weaker as demonstrated by DEXA scanning (bone mineral density measurement). Histological examination of the healing bone can give a definitive answer whether the bone was affected or not. Thus, the possibilities of studying NSAIDs affect on bone healing in humans and the clinical significance are very positive.
32 studies on the registry are indexed under Colles' Fracture; 4 are open to participants now.
This study's enrollment of 192 is above the median of 90 across 27 interventional studies indexed under Colles' Fracture.
Browse Colles' Fracture studies →Northern Orthopaedic Division, Denmark is the lead sponsor of 61 studies on the registry; 4 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patient are under sedation before reposition. The patient will be injected with 8-10 ml 1% Lidocain. After reposition the patient is asked to fill in a questionnaire with information of experienced pain based on VAS score. The patient note down the experience of pain each day 14 days after reposition.
Drug: Tablets Ibumetin and placebo
The method of surgery is type bridging. After surgery the patient is asked to fill in a questionnaire with information of experienced pain based on VAS score. The patient note down the experience of pain each day 14 days after operation.
Drug: Tablets Ibumetin and placebo
Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after reposition. Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after reposition. The following days placebo tablets. Group C: Placebo tablets 1 week after reposition.
Also known as: No other names.
Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after surgery. Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after surgery. The following days placebo tablets. Group C: Placebo tablets for 1 week after surgery.
Also known as: No other names.
Evaluation of dislocation.
By means of new radiographic technology the investigator is able to determine the difference between any migration of fragments precisely.
Time frame: An expected average of 5 weeks
Pain score by VAS scale.
Every patient keeps a pain log 2 weeks after surgery.
Time frame: An expected average of 2 weeks.
Bone Mineral Density.
By means of DEXA scanning the bone mineral density will be evaluated.
Time frame: An expected average of 3 months
Movement deflections.
Evaluation of flexion, extension, pronation and supination after 1 week, 2 weeks, 6 weeks and 3 months. DASH score after 3 months and 1 year.
Time frame: An expected average of 5 weeks
Predictors for bone healing.
To determine the predictors for bone healing in cooperation with Immunodiagnostic Systems.
Time frame: An expected average of 3 months
Determine ossification.
To perform a core biopsi in order to determinating ossification of callus.
Time frame: An expected average of 3 months
The record gives a start of Jun 2012, a primary completion of Mar 2020 and a completion of Mar 2021. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Northern Orthopaedic Division, Denmark